Duke paves way for science ideas

DURHAM - Duke University researchers who recently unveiled a new arthritis therapy are learning a language new to them - the language of business.

They're being schooled on the subject in the form of a new Duke grants program that helps researchers bridge the gap between the academic and business worlds. As its name implies, the Duke-Coulter Translational Partners Program is all about translating.

That's invaluable to Duke researchers such as Dr. Lori Setton, associate professor of biomedical engineering and orthopedic surgery. With a grant of $100,000 from the program, Setton, who led the research that produced the new arthritis drug, may see her team's work hit the market a year earlier than it would have otherwise, says Dr. George Truskey, chairman of Duke's Biomedical Engineering Department.

The year-old program similarly has armed three other Duke medical research teams with business expertise. Two have started spinoff companies to market their medical technologies, and the third is licensing the patent rights to a company that will market its technology.

"Without the Coulter grants, the four health-care technologies would have had a significantly harder time trying to get to the marketplace because the funding they got was critical to keeping the technologies moving forward," says Dr. Barry Myers, a Duke biomedical engineering professor who serves as project director for the Coulter program.

For Setton, the grant provided not only money for research but also essential guidance through the difficult middle zone of medical technology development known as the "valley of death." That zone is where promising new drugs and technologies emerging from basic research meet the harsh realities of business planning, patenting, licensing, U.S. Food and Drug Administration regulations and funding shortfalls.

Without funding, development of a new drug can languish in the "valley of death." It may never get to the next stage - the preclinical trials and, later, the clinical trials that precede manufacturing, marketing and sales.

But at Duke, the Coulter grants are changing all that for the research projects they fund.

Setton expects to conclude a licensing deal for the arthritis therapy in about six months. She isn't naming interested parties, but Truskey says the companies "are some of the biggest that sell arthritis drugs."

Both credit the Coulter grant.

Without it, Setton says, "we would have struggled more to get the attention of commercial parties and investors who are really necessary to translate the technology out."

"I don't think I would have understood the language necessary to communicate with those parties. And I would have focused longer on fundamental research problems that were not fundamental or critical to using the new drug," Setton says.

The program, initiated after Duke's biomedical engineering program became one of nine in 2005 to receive a partnership award from the Wallace H. Coulter Foundation, is providing $580,000 annually for the next five years. It aims at carrying proof-of-concept technology ideas through to a patentable product.

As important as the funding it provides is the pool of business expertise researchers can access through a project management team that helps with business planning, licensing and patents.

"They help facilitate the intellectual property issues," Truskey says. "They also work with people in the industry to make contacts and arrange for them to come visit Duke. They help streamline the process, and that's what happened in Lori's case."

Also, Truskey says, the team suggested experiments that would showcase the new therapy's possibilities and provided guidance on preparing and presenting the research to companies potentially interested in licensing deals.

Setton's team devised a new way to significantly prolong the effects of an anti-inflammatory drug, potentially making it useful for providing longer-lasting treatment for osteoarthritis, the most common form of arthritis. The modified drug, which would be injected directly into arthritic joints, could last for several weeks rather than just the few hours the unmodified drug would last.

"With this advance, we believe treatments could go from twice a week to perhaps twice a month, and that would be a huge clinical gain," Setton says.

The other three Duke research projects awarded Coulter grants also have seen success, with two resulting in spinoff companies, Myers says. One company, Cytex, specializes in bio-engineered cartilage replacement for hip-joint repair. The other markets an optical system that allows doctors to diagnose the success of breast cancer removal during surgery. The third technology is an improved cancer treatment that is in the licensing phase.